Arcturus Therapeutics Holdings Inc. - ARCT STOCK NEWS

Meiji Seika Pharma announced its investment in ARCALIS, a joint venture between Axcelead and Arcturus Therapeutics focused on mRNA pharmaceuticals and vaccines development. ARCALIS aims to establish comprehensive domestic production of mRNA vaccines in Japan. The collaboration combines ARCALIS' mRNA technology with Meiji's manufacturing expertise to improve vaccine supply in Japan. Meiji plans to supply the domestically produced KOSTAIVE® sa-mRNA vaccine in December 2024, using active ingredients from ARCALIS. This initiative aligns with Japan's strategy to strengthen vaccine development and production systems, ensuring timely delivery of vaccines when needed.

Arcturus Therapeutics (Nasdaq: ARCT) has received FDA clearance to proceed with a clinical trial for ARCT-2304, a self-amplifying mRNA vaccine candidate targeting H5N1 pandemic influenza. The Phase 1 clinical trial, funded by BARDA, will evaluate safety, reactogenicity, and immunogenicity in approximately 200 healthy adults in the United States. The vaccine utilizes Arcturus' STARR® self-amplifying mRNA technology and is part of the company's preparation efforts for potential future pandemics.

Arcturus Therapeutics reported Q3 2024 financial results and pipeline updates. Key highlights include a $25 million commercial milestone from first KOSTAIVE® sales in Japan, and Phase 2 studies for Cystic Fibrosis and OTC Deficiency on track for proof-of-concept data in H1 2025. Revenue was $41.7 million, down from $45.2 million in Q3 2023. Net loss improved to $6.9 million ($0.26 per share) compared to $16.2 million ($0.61 per share) last year. The company maintains a strong cash position of $294.1 million, with runway through Q1 2027.

Arcturus Therapeutics (Nasdaq: ARCT), a commercial mRNA vaccines and medicines company, announced it will release its Q3 2024 financial results on November 7, 2024, after market close. The company will also host a conference call and webcast at 4:30 pm ET on the same day to discuss the results and provide a corporate update. The call can be accessed domestically at 1-800-274-8461 and internationally at 1-203-518-9814 using the conference ID: ARCTURUS. A webcast link will be available for streaming.

CSL and Arcturus Therapeutics announced results from a head-to-head study showing their self-amplifying mRNA (sa-mRNA) COVID-19 vaccine ARCT-154 maintained superior immunogenicity compared to Comirnaty® for up to one year. The study, presented at the OPTIONS XII conference, demonstrated:

1. Higher antibody levels against multiple SARS-CoV-2 strains, including Wuhan-Hu-1 and Omicron variants.

2. Effectiveness at one-sixth the dose of Comirnaty® (5 μg vs 30 μg).

3. Superior durability of immune response in both younger and older adults.

Additionally, their bivalent vaccine ARCT-2301 showed superior immunogenicity over Comirnaty® bivalent vaccine up to six months post-vaccination. The sa-mRNA platform vaccine targeting the JN.1 variant is now approved in Japan under the name KOSTAIVE®.

CSL (CSLLY) and Arcturus Therapeutics announced results from a head-to-head study showing their self-amplifying mRNA (sa-mRNA) COVID-19 vaccine maintained superior immunogenicity compared to Comirnaty® for up to one year. The study, presented at the OPTIONS XII conference, demonstrated ARCT-154 elicited superior antibody persistence against multiple SARS-CoV-2 strains at one-sixth the dose of Comirnaty®.

Key findings include:

• ARCT-154 showed superior neutralizing antibodies against Wuhan-Hu-1 strain at Day 361
• Similar advantages were observed against Omicron BA.4-5 and other variants
• A bivalent formula, ARCT-2301, also demonstrated superior immunogenicity over Comirnaty®

The sa-mRNA COVID-19 vaccine is approved in Japan under the name KOSTAIVE® for adults 18 and older.

CSL (ASX:CSL; USOTC:CSLLY) and Arcturus Therapeutics announced that Japan's Ministry of Health, Labor and Welfare has approved their updated self-amplifying mRNA (sa-mRNA) COVID-19 vaccine, KOSTAIVE®, for adults 18 and older. The vaccine is tailored to protect against the JN.1 lineage of Omicron subvariants. Meiji Seika Pharma, CSL's exclusive partner in Japan, will distribute the vaccine for the October COVID-19 vaccination campaign.

KOSTAIVE® is the world's first commercially available sa-mRNA COVID-19 vaccine. Clinical evidence supports its safety and effectiveness, with data showing superior immunogenicity to Omicron BA 4/5 compared to conventional mRNA vaccines and immunity lasting up to one year. This approval aligns with recent World Health Organization recommendations and demonstrates CSL and Arcturus' commitment to innovative vaccine technology for viral respiratory diseases.

CSL and Arcturus Therapeutics announced that Japan's Ministry of Health, Labor and Welfare has approved their updated self-amplifying mRNA (sa-mRNA) COVID-19 vaccine, KOSTAIVE®, for adults 18 and older. The vaccine is tailored to protect against the JN.1 lineage of Omicron subvariants. Meiji Seika Pharma, CSL's exclusive partner in Japan, will distribute the vaccine for the October 2024 vaccination campaign.

KOSTAIVE® is the world's first commercially available sa-mRNA COVID-19 vaccine for adults. Clinical data showed superior immunogenicity to Omicron BA 4/5 compared to conventional mRNA vaccines and immunity lasting up to one year. This approval aligns with recent World Health Organization recommendations and demonstrates CSL and Arcturus' commitment to innovative vaccine technology for viral respiratory diseases.

Arcturus Therapeutics (Nasdaq: ARCT) has received FDA clearance for its Investigational New Drug (IND) application for ARCT-032, an inhaled mRNA therapeutic for cystic fibrosis (CF). This clearance allows Arcturus to initiate a Phase 2 multiple ascending dose study to evaluate the safety, tolerability, and efficacy of ARCT-032 in CF patients. The study will focus on individuals who do not qualify for or benefit from CFTR modulator therapy.

Dr. Juergen Froehlich, Chief Medical Officer of Arcturus, stated that this development provides an opportunity to further validate their LUNAR® technology for delivering mRNA via inhalation. The study will assess ARCT-032 administered over several weeks at multiple dose levels in CF patients.